Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K091943 |
Device Name |
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A |
Applicant |
CARDIAC SCIENCE CORPORATION |
3303 MONTE VILLA PKWY. |
BOTHELL,
WA
98021
|
|
Applicant Contact |
BEVERLY MAGRANE |
Correspondent |
CARDIAC SCIENCE CORPORATION |
3303 MONTE VILLA PKWY. |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
BEVERLY MAGRANE |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 06/30/2009 |
Decision Date | 09/10/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|